NCT05655598

TAS-116 Plus Palbociclib in Breast and Rb-null Cancer

Phase Ib IIT of Heat Shock Protein 90 Inhibitor TAS-116 Combined with Cyclin-dependent Kinase 4/6 Inhibitor Palbociclib in Advanced Breast Cancer Progressing on Palbociclib & Treatment-refractory Solid Tumors with Retinoblastoma Deficiency

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of TAS-116 with palbociclib in two groups of patients: * Patients with advanced breast cancer that has become worse after taking palbociclib alone * Patients with cancers that have an abnormality in a gene called the "retinoblastoma gene".

Conditions

• Advanced Breast Cancer
• Treatment-Refractory Solid Tumors
• Retinoblastoma Deficiency
• SCLC
• Soft Tissue Sarcoma
• Endometrial Cancer
• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Palbociclib Oral Product	125 mg/day (FDA approved dose) or the last tolerated dose before progression for 21 days of a 28-day cycle
DRUG	TAS-116	120 mg/day, 5 days on 2 days off, for days 1-28 of a 28 day cycle
DRUG	TAS-116	80 mg/day, 5 days on 2 days off, for days 1-28 of a 28 day cycle
DRUG	TAS-116	40 mg/day, 5 days on 2 days off, for days 1-28 of a 28 day cycle

Timeline

• Start date: 2023-09-12
• Primary completion: 2024-08-05
• Completion: 2024-08-05
• First posted: 2022-12-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study